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The disposable PACK & PROPER Ear-Thermometer Prove Cap is used to protect probe of ear thermometer and prevent cross-infection.

Pack & Proper, Ear-Thermometer Probe Cap

The provided text is a 510(k) clearance letter from the FDA for the Pack & Proper Ear-Thermometer Probe Cap. This document is a regulatory approval and does not contain the acceptance criteria and study details requested in your prompt.

The 510(k) process is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if different technological characteristics, that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.

While the FDA's decision is based on a review of submitted information, the specific details of performance testing, acceptance criteria, sample sizes, ground truth establishment, or human reader studies are not typically included in the public 510(k) summary or the clearance letter itself. These details would have been part of the manufacturer's submission to the FDA.

Therefore, I cannot provide the requested information based on the input text.

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